Predictive Effect of Neuroinflammatory Factors of the MECT in Treatment of Senile Depression

NCT05597566 | Unknown

• 1 other identifier: KM202010025011
• Study Type: observational
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

To compare the correlation between the clinical efficacy of MECT treatment and baseline, 3 times, 8 times of treatment, 1 week after treatment, and 2 weeks after treatment in patients with depression and suicidal ideation. The prediction effect of -1β and IL-6 levels and level changes on the efficacy of MECT in the treatment of suicidal ideation in elderly patients with depression, and provide a theoretical basis for further research on the mechanism of MECT in the treatment of elderly depression with suicidal ideation.

Conditions

Major Depression Disorder

Keywords

neuroinflammatory factors; modified electroconvulsive therapy(MECT)

Outcome Measures

Primary Outcomes (1)

• Change level of IL-6 compared with baseline at the end of MECT treatment.

  Serum IL-6 levels were measured at baseline, 3 times of treatment, 8 times of treatment, 1 week of treatment and 2 weeks of treatment. At the same time, SIOSS, BSI-CV, HDRS-17 and MADRS were used to comprehensively evaluate the clinical symptoms of elderly patients with depression.

  baseline;through treatment 3 times, an average of 3 day;through treatment 8 times, an average of two weeks; three weeks;four weeks

Secondary Outcomes (1)

• Change level of IL-1β compared with baseline at the end of MECT treatment.

  baseline;through treatment 3 times, an average of 3 day;through treatment 8 times, an average of two weeks; three weeks;four weeks

Study Arms (1)

Elderly depression patients with suicidal ideation

Conformity: Age 60-85 years old; meet DSM-5 diagnostic criteria for major depressive disorder; currently in acute phase, HDRS-17 ≥ 24; history of suicide attempt in this depressive episode; current suicidal ideation, SIOSS ≥ 12.Exclusions: Patients with unstable physical diseases; patients currently suffering from acute inflammatory infection or chronic inflammatory disease; participated in another interventional clinical study within the past 1 month; previous or current diagnosis of other psychiatric diseases by DSM-IV ; abuse of alcohol and active drugs within 12 months, except for nicotine; severe aphasia, visual and hearing impairment, etc. unable to complete the scale evaluation; MECT treatment contraindications; pregnant, lactating women or planning pregnancy; allergic to propofol and succinylcholine chloride.

Procedure: modified electroconvulsive therapy

Interventions

modified electroconvulsive therapy PROCEDURE

The patient underwent MECT therapy. The treatment instrument is Xingmaitong IV ECT multifunctional treatment instrument (USA, SOMATICS THYMATRON company), fasting for 6 hours before surgery, emptying urine. Routine preoperative preparations were made, followed by intravenous injection of atropine, propofol, and succinylcholine chloride injection, artificial respiration, placement of dental pads, and electroconvulsive therapy. The whole process is completed by an anesthesiologist and a therapist in cooperation with each other. The first 3 times are once a day, and the next 5 times are once every other day. A total of 8 courses of treatment.

Elderly depression patients with suicidal ideation

Eligibility Criteria

• Age: 60 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All subjects were from elderly patients with depression who were hospitalized in Beijing Anding Hospital Affiliated to Capital Medical University.

You may qualify if:

• Provide written informed consent; Age 60 to 85 years old, including 60 and 85 years old;
• Meet the diagnostic criteria for single or recurrent major depressive disorder in DSM-5 (Diagnostic and Statistical Manual of Mental Disorders, 5th Edition);
• Currently in the acute phase, with a total score of 17-item Hamilton Depression Rating Scale (HDRS-17) ≥ 24 at baseline;
• History of suicide attempt in this depressive episode; Rating Scale (SIOSS)≥12 points;

You may not qualify if:

• Patients with a history of epilepsy or coronary heart disease or other serious unstable physical diseases;
• Patients with acute inflammatory infection or chronic inflammatory disease; Patients in the past 1 month Participated in another interventional clinical study;
• Past or current diagnosis of the following psychiatric diseases by DSM-IV: organic mental disorder, Alzheimer's disease, secondary dementia due to other causes, mental illness Schizophrenia, schizoaffective disorder, bipolar disorder, delusional disorder, unspecified mental illness, and patients with a history of drug abuse, including alcohol and active drug abuse in the past 12 months, except for nicotine;
• Severe aphasia , visual and hearing impairment, etc. who cannot complete the scale evaluation;
• Those who have contraindications to MECT treatment;
• Those who are pregnant, lactating women or planning to become pregnant; Those who are allergic to atropine, propofol, and succinylcholine chloride.

Sponsors & Collaborators

• Qinge Zhang: lead

Study Sites (1)

Beijing Anding Hospital Affiliated to Capital Medical University

Beijing, Beijing Municipality, China

RECRUITING

Related Publications (4)

• Liu J, Yan F, Ma X, Guo HL, Tang YL, Rakofsky JJ, Wu XM, Li XQ, Zhu H, Guo XB, Yang Y, Li P, Cao XD, Li HY, Li ZB, Wang P, Xu QY. Prevalence of major depressive disorder and socio-demographic correlates: Results of a representative household epidemiological survey in Beijing, China. J Affect Disord. 2015 Jul 1;179:74-81. doi: 10.1016/j.jad.2015.03.009. Epub 2015 Mar 14.

  PMID: 25845752 RESULT

• Guerra M, Prina AM, Ferri CP, Acosta D, Gallardo S, Huang Y, Jacob KS, Jimenez-Velazquez IZ, Llibre Rodriguez JJ, Liu Z, Salas A, Sosa AL, Williams JD, Uwakwe R, Prince M. A comparative cross-cultural study of the prevalence of late life depression in low and middle income countries. J Affect Disord. 2016 Jan 15;190:362-368. doi: 10.1016/j.jad.2015.09.004. Epub 2015 Oct 23.

  PMID: 26544620 RESULT

• Carlier A, van Exel E, Dols A, Bouckaert F, Sienaert P, Ten Kate M, Wattjes MP, Vandenbulcke M, Stek ML, Rhebergen D. The course of apathy in late-life depression treated with electroconvulsive therapy; a prospective cohort study. Int J Geriatr Psychiatry. 2018 May 30. doi: 10.1002/gps.4917. Online ahead of print.

  PMID: 29851173 RESULT

• Obbels J, Verwijk E, Vansteelandt K, Dols A, Bouckaert F, Schouws S, Vandenbulcke M, Emsell L, Stek M, Sienaert P. Long-term neurocognitive functioning after electroconvulsive therapy in patients with late-life depression. Acta Psychiatr Scand. 2018 Sep;138(3):223-231. doi: 10.1111/acps.12942. Epub 2018 Jul 12.

  PMID: 30003550 RESULT

Study Officials

• Qing e Zhang, PhD

  Beijing Anding Hospital Affiliated to Capital Medical University

  STUDY CHAIR

Central Study Contacts

Man Liu

CONTACT

+8658340200; 473422818@qq.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 20, 2022
• First Posted: October 28, 2022
• Study Start: June 1, 2021
• Primary Completion: October 31, 2022
• Study Completion: December 31, 2022
• Last Updated: October 28, 2022

Record last verified: 2022-10

Locations

CN (1)